Company Product Description Indication Status
Acasti Pharma Inc., of Laval, Québec Capre (omega-3 phospholipid) Purified from krill oil Severe hypertriglyceridemia Filed the prespecified statistical analysis plan for the phase III Trilogy 2 study with the FDA
Ascletis Pharma Inc., of Hangzhou, China RDV/DNV regimen Ravidasvir and danoprevir  Hepatitis C infection China's National Medical Products Administration approved the treatment
Eisai Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J. Lenvima (lenvatinib mesylate) Multiple receptor tyrosine kinase inhibitor Unresectable thymic carcinoma Submitted a marketing application in Japan
Fortress Biotech Inc., of New York CUTX-101 Copper histidinate Menkes disease Received a positive opinion on orphan drug designation from the EMA
Janssen Pharmaceutical Cos., of Beerse, Belgium, part of Johnson & Johnson Stelara (ustekinumab) Targets IL-23/IL-12 pathway Moderate to severe plaque psoriasis FDA approved for the treatment of pediatric patients with moderate to severe plaque psoriasis
Redhill Biopharma Ltd., of Tel Aviv, Israel RHB-204 Fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine Pulmonary nontuberculous mycobacteria infections FDA cleared its IND application for a pivotal phase III study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium complex infection
Revive Therapeutics Ltd., of Toronto Bucillamine Cysteine derivative with 2 thiol groups Mild to moderate COVID-19 FDA approved it to proceed with randomized, double-blind, placebo-controlled confirmatory phase III trial protocol to evaluate safety and efficacy 
Roche Holding AG, of Basel, Switzerland Tecentriq plus Cotellic and Zelboraf  Atezolizumab plus cobimetinib and vemurafenib BRAF V600 mutation-positive advanced melanoma  FDA approved it
Sound Pharmaceuticals Inc., of Seattle SPI-1005 (ebselen) Glutathione peroxidase stimulator COVID-19 Filed an IND application with the FDA to begin phase II studies

Notes

For more information about individual companies and/or products, see Cortellis.

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